
SAAB AKTIEBOLAG · Linköping
Vill du påverka och göra skillnad på riktigt? Här bidrar du till att skapa trygghet för människor och samhällen. Det du gör spelar roll. Din roll Som SME för Fa...
Vill du påverka och göra skillnad på riktigt? Här bidrar du till att skapa trygghet för människor och samhällen. Det du gör spelar roll.
Din roll
Som SME för Facility Management System (FMS) ansvarar du för att Saabs globala fastighetssystem utvecklas, förvaltas och används på ett sätt som skapar långsiktigt värde. Du har ett helhetsansvar för att säkerställa att verksamhetens behov, prioriteringar och krav omsätts i lösningar genom nära samarbete mellan Property, IT, Security, Procurement och externa leverantörer.
Rollen kombinerar strategiskt, taktiskt och operativt ansvar. Inom förvaltningen arbetar du enligt PM3-modellen i rollen som Business Solution Manager (BSM). Under året blir du även en nyckelperson i den pågående migreringen av FMS till en molnlösning.
Driva utveckling och förvaltning av FMS tillsammans med Business Service Owner (BSO) utifrån verksamhetens behov.
Identifiera, samordna och prioritera globala behov, krav och förändringsinitiativ i nära samarbete med Property, IT, leverantörer och partners.
Vara länken mellan verksamheten och IT samt säkerställa att lösningar möter verksamhetens krav.
Ta fram och följa upp förvaltningsplan, roadmap och budget tillsammans med IT och leverantör.
Säkerställa att FMS är single source of truth för Saabs globala location- och masterdata samt utveckla relevanta integrationer.
Bidra till Property IT-teamets digitaliseringsarbete, inklusive AI och datadrivet beslutsstöd.
Driva frågor från behov till genomförande med fokus på säkerhet, kvalitet och långsiktighet.
Vi söker dig som är trygg i en senior roll och har erfarenhet av verksamhetskritiska system i komplexa organisationer. Du kan ha en bakgrund inom verksamhet eller IT, men har förmågan att förstå båda perspektiven och omsätta behov till hållbara lösningar.
IT Management, systemförvaltning, kravhantering, integrationer och test.
Facility Management, exempelvis drift och förvaltning av fastigheter och arbetsplatser.
Projektledning, gärna inom bygg- eller fastighetsprojekt.
Processutveckling och kontinuerligt förbättringsarbete.
Dokumentation samt framtagning av användarstöd, utbildningsmaterial och rutiner.
Vad du blir en del av
Upptäck oändliga möjligheter. Anta utmaningar, skapa smarta innovationer och uppgradera dina förmågor. Det här är en plats för kluriga tänkare, modiga pionjärer och alla däremellan. Tillsammans uppnår vi det extraordinära, var och en tar med sitt unika perspektiv. Varje bidrag räknas.
Saab är ett ledande försvars- och säkerhetsföretag med syfte att hjälpa nationer att skydda sin befolkning och bidra till trygghet för människor och samhällen. Med 28 000 talangfulla medarbetare utvecklar Saab teknik och lösningar för en säkrare och mer hållbar värld.
Saab utvecklar, tillverkar och underhåller avancerade system inom flygteknik, vapen, ledningssystem, sensorer och undervattenssystem. Saab har sitt huvudkontor i Sverige men en global verksamhet där Saab är en del av många nationers försvarsförmåga. Läs mer om oss här.
Med tanke på den kommande semesterperioden kan du förvänta dig återkoppling på din ansökan efter sommaren. Om du tycker att tjänsten låter intressant är du varmt välkommen att skicka in din ansökan redan idag!
Description QA Risk Management Sr Engineer Summary This is an exciting opportunity to build and lead the quality risk management program at a growing, world-class CDMO specializing in sterile injectable drug products and combination product assembly. As a member of the Technical Systems team within Quality Assurance, you will serve as the site subject matter expert (SME) for quality risk management, partnering across Manufacturing, Engineering, Validation, Quality, and Project Management to embed risk-based thinking into every facet of our operations. If you thrive on creating foundational programs from the ground up and want to make a meaningful impact on patient safety, this role is for you. Reporting to the QA Manager of Technical Systems, the QA Risk Management Sr Engineer is responsible for developing and implementing corporate quality risk management policies, procedures, and tools in compliance with ICH Q9, ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and applicable EU regulations. This role will establish and maintain the site risk register, provide SME oversight of risk assessments across deviations, change controls, engineering projects, validation activities, medical device and combination product operations, manufacturing processes, and continuous improvement initiatives. The QA Risk Management Sr Engineer will prepare risk management reports and metrics for Quality System Management Review and serve as the QA representative ensuring risk-based decision-making is consistently applied across the organization. Essential Job Functions: Develop, implement, and maintain corporate quality risk management policies, procedures, and work instructions in alignment with ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20 Establish and manage the site-wide Quality Risk Register, ensuring risks are identified, evaluated, controlled, reviewed, and communicated in a timely manner Serve as the QA subject matter expert (SME) for quality risk management, providing oversight and guidance on risk assessments (FMEA, FTA, HACCP, PHA, and other ICH Q9 tools) across all site functions Provide QA risk management oversight for deviations, investigations, CAPAs, and change controls, ensuring risk-based rationale is documented and defensible Support and oversee risk assessments associated with engineering projects, facility and equipment qualification, and validation lifecycle activities Provide QA risk management oversight for medical device and combination product (autoinjector, prefilled syringe, and similar device) assembly operations, ensuring compliance with ISO 13485 and ISO 14971 requirements Author and manage risk management files for combination products and device assembly processes as required by 21 CFR Part 820 and ISO 14971 Prepare and present quality risk management metrics, trending data, and summary reports for Quality System Management Review meetings Partner with cross-functional teams including Manufacturing, Engineering, Technical Services, Supply Chain, Validation, and Project Management to embed risk-based thinking into daily operations and continuous improvement initiatives Facilitate and lead risk assessment workshops, training sessions, and coaching for site personnel on quality risk management principles and tools Support regulatory inspections and client audits as the risk management SME, including preparation of risk-related documentation and responses Monitor and evaluate changes in regulatory guidance, industry standards, and best practices related to quality risk management and recommend updates to site practices accordingly Ensure integration of risk management activities with the site Contamination Control Strategy (CCS) and overall Quality Management System (QMS) Special Job Requirements: Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related scientific discipline; advanced degree preferred Minimum of 7 years of experience in quality assurance, quality risk management, or a related function within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment Demonstrated experience developing and implementing quality risk management programs, including authoring risk management policies, SOPs, and risk assessment tools Strong working knowledge of ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20 Hands-on experience with formal risk assessment methodologies including FMEA, FTA, HACCP, and Preliminary Hazard Analysis (PHA) Experience in aseptic/sterile injectable drug product manufacturing or parenteral fill-finish operations Excellent written and verbal communication skills with the ability to present risk information clearly to technical and executive audiences Additional Preferences: Experience with combination product (drug-device) risk management and familiarity with autoinjector or prefilled syringe device assembly processes ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or equivalent professional certification, ISO 13485 or related certifications Experience establishing a site risk register and integrating risk management outputs into Quality System Management Review Prior experience at a contract development and manufacturing organization (CDMO) Working knowledge of EU GMP Annex 1 (2022) Contamination Control Strategy requirements and integration of risk management into CCS Experience supporting FDA, EMA, and/or client regulatory inspections and audits as a risk management subject matter expert Familiarity with ISPE risk management guidance, PDA Technical Reports, and ASTM E2500 as applied to pharmaceutical and medical device manufacturing Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.
About Yondr Yondr is a disruptor. We challenge convention and simplify complexity. A global developer, owner operator and service provider of data centers, we deliver complex data center capacity needs for the world’s largest tech companies. Our exponential growth sees us looking for extraordinary people to help accelerate us towards our vision: a tomorrow without constraints. But we can’t do this without you. About the Role As the Operations Engineer – Mechanical, EMEA (SME), you provide mechanical technical authority across our regional data centers. You will define and drive the mechanical operations philosophy and standards, support Regional Technical Managers and site teams as an escalation point during incidents, and provide input to design and commissioning to ensure systems are operable, maintainable, and resilient throughout the asset lifecycle. The role balances safety, availability, cost, and customer/SLA requirements and partners closely with design & construction, facility management, OEMs, and contractors. Main Responsibilities This position will have overall responsibility for all mechanical aspects of our regional data centers including, but not limited to, planned and corrective maintenance, technical documentation, review of proposed operational procedures, initial analysis of in-service failures, associated project work, and overall system health. The Operation Senior Engineer is responsible for the evaluation and rollout of engineering initiatives along with leading small to medium-scale projects. Interacts with internal and external teams, including design and construction management of new facilities and Yondr facility management and operations. This position coordinates with other regional operational engineering roles and is a member of the global operational engineering within Yondr. * Provide mechanical technical subject matter expertise (SME) across the region, including cooling plant, airside systems, hydronic systems, and associated sequence of operation. * Develop and drive the overall philosophy and standards for site mechanical SMEs, including guidance for SOPs, MOPs, and EOPs and mechanical portions of technical documentation. * Serve as the regional mechanical technical authority during incidents, providing remote/on-site escalation support, recommending response and recovery actions, and supporting the site incident commander to restore systems safely and rapidly while managing risk and customer/SLA impacts. * Provide specific technical input to root cause analyses (RCAs), including failure mode assessment, contributing factors, corrective/preventative actions, and assist with managing third-party experts in RCAs as needed. * Review non-routine/high-impact maintenance and change activity (including contractor RAMS) to ensure appropriate risk controls, method, temporary configuration, and return-to-service criteria. * Provide operational input to design, construction, and commissioning for existing and new facilities, ensuring operability, maintainability, and alignment with the mechanical operations strategy. * Represent Yondr Operations during the commissioning activities ensuring readiness to operate and handover acceptance criteria are met for mechanical areas. * Oversee post-delivery mechanical and controls-related technical items/changes to ensure no adverse impact to system availability or customer SLAs as tenants implement changes throughout the site lifecycle. * Lead/enable lifecycle management for mechanical assets, including evaluation of solutions, repair/replacement strategies, and inputs to capital planning. * Develop, review, and maintain up to date the maintenance philosophy beyond e.g. preventative maintenance strategy (pre and post warranty scope, maintenance intervals), OEM alignment, and spares philosophy/critical spares. * Assist sites as the technical interface with OEMs and vendors for chronic issues, design defects, firmware issues/updates, sequence changes, etc. * Review, develop (as needed), and deliver mechanical technical training to reduce reliance on external training providers and build capability within site teams. * Coordinate with overall operational engineering team and Critical Environment Management (CEM) team to maintain a knowledge base of standard fixes, known failure modes, lessons learned, technical bulletins, and overall data center mechanical knowledge. * Attending required meetings with key stakeholders to represent Operations in technical discussions. * Maintain effective administration of projects and core responsibilities, including timely documentation and stakeholder updates, to ensure transparency on the mechanical scope described above. * Maintain strong Health & Safety awareness in all operational engineering activities. * Other tasks as assigned. Qualifications and experience * Bachelor’s degree in an applicable engineering field preferred, experience would be considered in lieu of a Bachelor’s. * 8 -10 years of relevant experience (with 5+ years of experience working in data centers and/or critical environments preferred). * Demonstrated skills and experience in the design, maintenance, and operation of critical mechanical systems in critical environments, preferably data centers (e.g., chillers, CRAH/CRAC, cooling towers/dry coolers, pumps/valves, heat exchangers, ventilation systems, and hydronic distribution), including understanding of equipment sequences and commissioning/retro-commissioning. * Experienced in the delivery of highly complex technical projects. * Evidence of strong interpersonal skills is essential. * Strong verbal and written communication skills. * Results oriented, highly accountable, and strong organizational skills. * Proven self-starter. * Attention to detail and the ability to understand the big picture. * Ability to perform through change and transformation while adapting to shifting priorities. Skills and Experience * Show good team leadership skills and can lead by example. * Excellent people management skills, with the confidence to lead and motivate the team and those around you. * Excellent interpersonal and communication skills. * Broad experience in managing critical environments, data centres or smart buildings. * Good problem-solving and analytical skills. * Ability to multitask and thrive in a fast-paced regional and global business * Good, clear and precise delegation skills * Sensitive to political situations - good relationship builder Person specification * Passionate about what you do and committed to excellence – leads and holds people to account * Detail oriented and diligent. * Entrepreneurial by nature with a strong sense of ownership. * Decision maker. * Results orientated and prepared to take ownership of outcomes * Support the success of other people and their businesses above your own success * Role model our values * Excellent external radar so that they pick up on trends * Proactive, diligent, able and willing to think ahead * Ability to understand the wider picture whilst devoting attention to detail At Yondr, we want to enhance the diversity, equity, inclusion and belonging of our workforce to reflect the world we live in. Our roles are potential opportunities for everyone; all interested parties, regardless of nationality, race, ethnicity, religion, age, sexual orientation, or gender, are welcome to apply. We ensure all candidates have equitable access and consideration throughout the hiring process. Yondr is committed to fostering a welcoming, safe and inclusive work environment. We provide support through our benefits, which are inclusive of all backgrounds.
About Yondr Yondr is a disruptor. We challenge convention and simplify complexity. A global developer, owner operator and service provider of data centers, we deliver complex data center capacity needs for the world’s largest tech companies. Our exponential growth sees us looking for extraordinary people to help accelerate us towards our vision: a tomorrow without constraints. But we can’t do this without you. About the Role As the Operations Engineer – Mechanical, AMER (SME), you provide mechanical technical authority across our regional data centers. You will define and drive the mechanical operations philosophy and standards, support Regional Technical Managers and site teams as an escalation point during incidents, and provide input to design and commissioning to ensure systems are operable, maintainable, and resilient throughout the asset lifecycle. The role balances safety, availability, cost, and customer/SLA requirements and partners closely with design & construction, facility management, OEMs, and contractors. Main Responsibilities This position will have overall responsibility for all mechanical aspects of our regional data centers including, but not limited to, planned and corrective maintenance, technical documentation, review of proposed operational procedures, initial analysis of in-service failures, associated project work, and overall system health. The Operation Senior Engineer is responsible for the evaluation and rollout of engineering initiatives along with leading small to medium-scale projects. Interacts with internal and external teams, including design and construction management of new facilities and Yondr facility management and operations. This position coordinates with other regional operational engineering roles and is a member of the global operational engineering within Yondr. * Provide mechanical technical subject matter expertise (SME) across the region, including cooling plant, airside systems, hydronic systems, and associated sequence of operation. * Develop and drive the overall philosophy and standards for site mechanical SMEs, including guidance for SOPs, MOPs, and EOPs and mechanical portions of technical documentation. * Serve as the regional mechanical technical authority during incidents, providing remote/on-site escalation support, recommending response and recovery actions, and supporting the site incident commander to restore systems safely and rapidly while managing risk and customer/SLA impacts. * Provide specific technical input to root cause analyses (RCAs), including failure mode assessment, contributing factors, corrective/preventative actions, and assist with managing third-party experts in RCAs as needed. * Review non-routine/high-impact maintenance and change activity (including contractor RAMS) to ensure appropriate risk controls, method, temporary configuration, and return-to-service criteria. * Provide operational input to design, construction, and commissioning for existing and new facilities, ensuring operability, maintainability, and alignment with the mechanical operations strategy. * Represent Yondr Operations during the commissioning activities ensuring readiness to operate and handover acceptance criteria are met for mechanical areas. * Oversee post-delivery mechanical and controls-related technical items/changes to ensure no adverse impact to system availability or customer SLAs as tenants implement changes throughout the site lifecycle. * Lead/enable lifecycle management for mechanical assets, including evaluation of solutions, repair/replacement strategies, and inputs to capital planning. * Develop, review, and maintain up to date the maintenance philosophy beyond e.g. preventative maintenance strategy (pre and post warranty scope, maintenance intervals), OEM alignment, and spares philosophy/critical spares. * Assist sites as the technical interface with OEMs and vendors for chronic issues, design defects, firmware issues/updates, sequence changes, etc. * Review, develop (as needed), and deliver mechanical technical training to reduce reliance on external training providers and build capability within site teams. * Coordinate with overall operational engineering team and Critical Environment Management (CEM) team to maintain a knowledge base of standard fixes, known failure modes, lessons learned, technical bulletins, and overall data center mechanical knowledge. * Attending required meetings with key stakeholders to represent Operations in technical discussions. * Maintain effective administration of projects and core responsibilities, including timely documentation and stakeholder updates, to ensure transparency on the mechanical scope described above. * Maintain strong Health & Safety awareness in all operational engineering activities. * Other tasks as assigned. Qualifications and experience * Bachelor’s degree in an applicable engineering field preferred, experience would be considered in lieu of a Bachelor’s. * 8 -10 years of relevant experience (with 5+ years of experience working in data centers and/or critical environments preferred). * Demonstrated skills and experience in the design, maintenance, and operation of critical mechanical systems in critical environments, preferably data centers (e.g., chillers, CRAH/CRAC, cooling towers/dry coolers, pumps/valves, heat exchangers, ventilation systems, and hydronic distribution), including understanding of equipment sequences and commissioning/retro-commissioning. * Experienced in the delivery of highly complex technical projects. * Evidence of strong interpersonal skills is essential. * Strong verbal and written communication skills. * Results oriented, highly accountable, and strong organizational skills. * Proven self-starter. * Attention to detail and the ability to understand the big picture. * Ability to perform through change and transformation while adapting to shifting priorities. Skills and Experience * Show good team leadership skills and can lead by example. * Excellent people management skills, with the confidence to lead and motivate the team and those around you. * Excellent interpersonal and communication skills. * Broad experience in managing critical environments, data centres or smart buildings. * Good problem-solving and analytical skills. * Ability to multitask and thrive in a fast-paced regional and global business * Good, clear and precise delegation skills * Sensitive to political situations - good relationship builder Person specification * Passionate about what you do and committed to excellence – leads and holds people to account * Detail oriented and diligent. * Entrepreneurial by nature with a strong sense of ownership. * Decision maker. * Results orientated and prepared to take ownership of outcomes * Support the success of other people and their businesses above your own success * Role model our values * Excellent external radar so that they pick up on trends * Proactive, diligent, able and willing to think ahead * Ability to understand the wider picture whilst devoting attention to detail At Yondr, we want to enhance the diversity, equity, inclusion and belonging of our workforce to reflect the world we live in. Our roles are potential opportunities for everyone; all interested parties, regardless of nationality, race, ethnicity, religion, age, sexual orientation, or gender, are welcome to apply. We ensure all candidates have equitable access and consideration throughout the hiring process. Yondr is committed to fostering a welcoming, safe and inclusive work environment. We provide support through our benefits, which are inclusive of all backgrounds.